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肌肉骨骼癥狀是芳香酶抑制劑最常見的不良反應(yīng)，通常導(dǎo)致治療無法完成。既往小樣本低質(zhì)量研究表明,，針刺療法可能減少芳香酶抑制劑所致關(guān)節(jié)癥狀。 2018年7月10日,，《美國(guó)醫(yī)學(xué)會(huì)雜志》正刊正式發(fā)表紐約哥倫比亞大學(xué),、弗雷德哈欽森癌癥研究中心、西南腫瘤學(xué)組,、紐約西奈山醫(yī)院,、凱澤永久醫(yī)療中心、斯百全醫(yī)療集團(tuán),、格林維爾醫(yī)療集團(tuán),、圣盧克腫瘤研究所、國(guó)家癌癥研究所,、AIM醫(yī)療集團(tuán),、猶他大學(xué)癌癥研究所的隨機(jī)對(duì)照研究報(bào)告，確定了針刺療法減少芳香化酶抑制劑所致關(guān)節(jié)疼痛的效果,。 該多中心隨機(jī)對(duì)照研究于2012年3月～2017年2月在美國(guó)11個(gè)學(xué)術(shù)中心和臨床機(jī)構(gòu)進(jìn)行,，最后隨訪日期為2017年9月5日?；颊呷虢M條件為早期乳腺癌絕經(jīng)后女性,，服用芳香酶抑制劑，并且簡(jiǎn)化疼痛量表最痛項(xiàng)目（BPI-WP，評(píng)分范圍0～10,，評(píng)分越高表示越痛）評(píng)分≥3分,。將患者按2∶1∶1隨機(jī)分入真穴位針刺組（110例）、假穴位針刺組（59例）或等候者對(duì)照組（57例）,。真穴位針刺和假穴位針刺方案包括每周針刺2次×6周→每周針刺1次×6周,。等候者對(duì)照組未予任何干預(yù)。所有參與者均于24～52周接受10次針刺,。主要研究終點(diǎn)為6周BPI-WP評(píng)分,。通過線性回歸比較研究組6周BPI-WP平均評(píng)分，根據(jù)入組時(shí)疼痛和分層因素進(jìn)行校正（預(yù)設(shè)相差2分為有臨床意義）,。 結(jié)果,，隨機(jī)入組患者共226例（平均年齡60.7±8.6歲，白人占88%,，入組時(shí)BPI-WP平均評(píng)分6.6±1.5）,，完成研究共206例（91.1%）。入組至6周,，觀察到BPI-WP平均評(píng)分變化：
經(jīng)過校正,，真穴位針刺組：
真穴位針刺組與假穴位針刺組相比,，患者發(fā)生1級(jí)皮下瘀血較多（47%比25%，P=0.01）,。 因此,，對(duì)于早期乳腺癌絕經(jīng)后女性芳香酶抑制劑所致關(guān)節(jié)疼痛，真穴位針刺與假穴位針刺或等候者對(duì)照組相比,，6周時(shí)關(guān)節(jié)疼痛顯著減輕,，統(tǒng)計(jì)學(xué)意義確定，臨床意義不確定,。 相關(guān)閱讀 JAMA. 2018 Jul 10;320(2):167-176. Effect of Acupuncture vs Sham Acupuncture or Waitlist Control on Joint Pain Related to Aromatase Inhibitors Among Women With Early-Stage Breast Cancer: A Randomized Clinical Trial. Hershman DL, Unger JM, Greenlee H, Capodice JL, Lew DL, Darke AK, Kengla AT, Melnik MK, Jorgensen CW, Kreisle WH, Minasian LM, Fisch MJ, Henry NL, Crew KD. Columbia University Medical Center, New York, New York; Fred Hutchinson Cancer Research Center, Seattle, Washington; SWOG Statistics and Data Management Center, Seattle, Washington; Mount Sinai Hospital, New York, New York; Kaiser Permanente Medical Center, Walnut Creek, California; Spectrum Health Medical Group, Grand Rapids, Michigan; NCORP of the Carolinas (Greenville Health System), Greenville, South Carolina; St Luke's Mountain States Tumor Institute (PCRC NCORP), Boise, Idaho; National Cancer Institute, Bethesda, Maryland; AIM Specialty Health, Chicago, Illinois; University of Utah Huntsman Cancer Institute, Salt Lake City. This randomized clinical trial compares true acupuncture with sham acupuncture and with waitlist control on the reduction of joint pain related to aromatase inhibitor use in postmenopausal women with early-stage breast cancer. QUESTION: Does acupuncture reduce joint pain related to aromatase inhibitors among postmenopausal women with early-stage breast cancer? FINDINGS: In this multicenter randomized clinical trial of 226 women with early-stage breast cancer, patients in the acupuncture group, compared with those in the sham acupuncture group or the waitlist control group, had significant reductions in changes in joint pain scores from baseline to 6 weeks (between-group difference vs sham acupuncture, 0.92 points and 0.96 points vs the waitlist control group [0- to 10-point scale]). MEANING: Acupuncture was associated with statistically significant reductions in aromatase inhibitor-related joint pain at 6 weeks, although the magnitude of the improvement was of uncertain clinical importance. IMPORTANCE: Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors and often result in therapy discontinuation. Small studies suggest that acupuncture may decrease aromatase inhibitor-related joint symptoms. OBJECTIVE: To determine the effect of acupuncture in reducing aromatase inhibitor-related joint pain. DESIGN, SETTING, AND PATIENTS: Randomized clinical trial conducted at 11 academic centers and clinical sites in the United States from March 2012 to February 2017 (final date of follow-up, September 5, 2017). Eligible patients were postmenopausal women with early-stage breast cancer who were taking an aromatase inhibitor and scored at least 3 on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0-10; higher scores indicate greater pain). INTERVENTIONS: Patients were randomized 2:1:1 to the true acupuncture (n=110), sham acupuncture (n=59), or waitlist control (n=57) group. True acupuncture and sham acupuncture protocols consisted of 12 acupuncture sessions over 6 weeks (2 sessions per week), followed by 1 session per week for 6 weeks. The waitlist control group did not receive any intervention. All participants were offered 10 acupuncture sessions to be used between weeks 24 and 52. MAIN OUTCOMES AND MEASURES: The primary end point was the 6-week BPI-WP score. Mean 6-week BPI-WP scores were compared by study group using linear regression, adjusted for baseline pain and stratification factors (clinically meaningful difference specified as 2 points). RESULTS: Among 226 randomized patients (mean [SD] age, 60.7 [8.6] years; 88% white; mean [SD] baseline BPI-WP score, 6.6 [1.5]), 206 (91.1%) completed the trial. From baseline to 6 weeks, the mean observed BPI-WP score decreased by 2.05 points (reduced pain) in the true acupuncture group, by 1.07 points in the sham acupuncture group, and by 0.99 points in the waitlist control group. The adjusted difference for true acupuncture vs sham acupuncture was 0.92 points (95% CI, 0.20-1.65; P=.01) and for true acupuncture vs waitlist control was 0.96 points (95% CI, 0.24-1.67; P=.01). Patients in the true acupuncture group experienced more grade 1 bruising compared with patients in the sham acupuncture group (47% vs 25%; P=.01). CONCLUSIONS AND RELEVANCE: Among postmenopausal women with early-stage breast cancer and aromatase inhibitor-related arthralgias, true acupuncture compared with sham acupuncture or with waitlist control resulted in a statistically significant reduction in joint pain at 6 weeks, although the observed improvement was of uncertain clinical importance. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01535066 PMID: 29998338 DOI: 10.1001/jama.2018.8907
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